Association Between Cancer Center Accreditation and Compliance With Price Disclosure of Common Oncologic Surgical Procedures.

BACKGROUND: Cancer center accreditation status is predicated on several factors that measure high-value healthcare. However, price transparency, which is critical in healthcare decisions, is not a quality measure included for accreditation. We reported the rates of price disclosure of surgical procedures for 5 cancers (breast, lung, cutaneous melanoma, colon, and prostate) among hospitals ranked by the American College of Surgeon's Commission on Cancer (ACS-CoC). METHODS: We identified nonfederal, adult, and noncritical access ACS-CoC accredited hospitals and used the commercial Turquoise Health database to perform a cross-sectional analysis of hospital price disclosures for 5 common oncologic procedures (mastectomy, lobectomy, wide local excision for cutaneous melanoma, partial colectomy, prostatectomy). Publicly available financial reporting data were used to compile facility-specific features, including bed size, teaching status, Centers for Medicare & Medicaid wage index, and patient revenues. Modified Poisson regression evaluated the association between price disclosure and ACS-CoC accreditation after adjusting for hospital financial performance. RESULTS: Of 1,075 total ACS-CoC accredited hospitals, 544 (50.6%) did not disclose prices for any of the surgical procedures and only 313 (29.1%) hospitals reported prices for all 5 procedures. Of the 5 oncologic procedures, prostatectomy and lobectomy had the lowest price disclosure rates. Disclosing and nondisclosing hospitals significantly differed in ACS-CoC accreditation, ownership type, and teaching status. Hospitals that disclosed prices were more likely to receive Medicaid disproportionate share hospital payments, have lower average charge to cost ratios (4.53 vs 5.15; P<.001), and have lower net hospital margins (-2.03 vs 0.44; P=.005). After adjustment, a 1-point increase in markup was associated with a 4.8% (95% CI, 2.2%-7.4%; P<.001) higher likelihood of nondisclosure. CONCLUSIONS: More than half of the hospitals did not disclose prices for any of the 5 most common oncologic procedures despite ACS-CoC accreditation. It remains difficult to obtain price transparency for common oncologic procedures even at centers of excellence, signaling a discordance between quality measures visible to patients.

The Role of Opioids and Their Receptors in Urological Malignancy: A Review.

PURPOSE: We reviewed the literature surrounding the role of opioids and their receptors in urological malignancy. Recent studies have suggested clinically significant effects of agonism or antagonism of opioid receptors on cancer related outcomes and tumorigenesis. The focus of these efforts has centered on nonurological malignancies. However, a compelling body of evidence is growing in the fields of prostate, bladder and kidney cancer. MATERIALS AND METHODS: A systematic review of English language articles published through 2020 was conducted with key phrases related to kidney, bladder or prostate cancer, and opioids or narcotics. A total of 837 unique records were identified, of which 49 were selected for full text review and 33 were included in the qualitative analysis. Eight records were identified via citation review and 1 study was recently presented at a national meeting. RESULTS: Retrospective reviews suggest poorer disease specific and recurrence-free survival with increased perioperative opioid administration in patients undergoing prostate or bladder cancer surgery. However, the data are controversial. Kappa opioid receptors are implicated in both proliferation and inhibition of prostate cancer cell growth across in vitro studies, with a proposed interaction with the androgen cascade. Similarly opioid growth factor receptor is highly expressed in prostate cancer cells and repressed by androgens. Prostate cancer tissue stains more intensely for the mu opioid receptor, and patients with higher expression have poorer oncologic outcomes. Opioid agonism in vitro induces urothelial cell carcinoma proliferation, migration and invasion, with possible additional influence from interactions with the bradykinin b2 receptor. Agonism of the mu, kappa and delta opioid receptors induces renal cell carcinoma tumorigenesis, possibly via upregulation of survivin. Meanwhile, opioid growth factor receptor agonism has the opposite effect in renal cell carcinoma. CONCLUSIONS: Evidence surrounding the role of opioids and their receptors in urological malignancy is provocative and should serve as an impetus for further investigation.

The association between N-methylnaltrexone, a peripherally acting mu-opioid receptor antagonist, and clinical outcomes in patients undergoing robotic-assisted radical cystectomy.

PURPOSE: To assess the impact of N-methylnaltrexone, a peripherally acting mu-opioid receptor antagonist, on the post-operative recovery of patients undergoing robotic-assisted radical cystectomy for bladder cancer. METHODS: We retrospectively reviewed patients undergoing robotic-assisted radical cystectomy by a single surgeon (KC) prior to (control group) and after (treatment group) the routine use of N-methylnaltrexone. Kaplan-Meier curves and the log-rank test were used to quantify time to flatus, bowel movement, and discharge. Daily mean opioid use, daily pain assessment rating, and episodes of severe pain (7-10/10) were compared. Gastrointestinal-related complications, including ileus, emesis, and/or need for post-op nasogastric tube placement, and 30-day readmissions were also compared between groups. Charge capture data were compared between groups to analyze cost impact. RESULTS: 29 patients each in the control and treatment group met inclusion criteria. Patients receiving N-methylnaltrexone had reduced length of stay compared with no N-methylnaltrexone (median 4 vs. 7 days, p < 0.01). Time to flatus and bowel movement, however, were similar. In a multivariable analysis controlling for possible confounders, however, the improvement in length of stay associated with N-methylnaltrexone use did not reach statistical significance (p = 0.11). Episodes of severe pain and composite gastrointestinal-related complications were reduced in the N-methylnaltrexone group (44.8% vs. 10.3%, p < 0.01). The reduction in length of stay was associated with approximately $10,500 in cost savings per patient. CONCLUSIONS: In this study, N-methylnaltrexone was associated with reduced length of stay, fewer episodes of severe pain, and reduced costs. These results provide the impetus for further study.

Analysis of guideline recommended use of renal mass biopsy and association with treatment.

INTRODUCTION: Renal mass biopsy (RMB) may not be indicated when the results are unlikely to impact management, such as in young and/or healthy patients and in elderly and/or frail patients. We analyzed the utility of RMB in three patient cohorts stratified by age-adjusted Charlson comorbidity index score (ACCI). MATERIALS AND METHODS: We identified patients with cT1a renal tumors in the National Cancer Database from 2004-2014. We combined age and Charlson-Deyo scores to identify young and/or healthy patients ('healthy-ACCI'), elderly and/or frail patients ('frail-ACCI'), and a reference cohort. We performed multivariable logistic regression to identify predictors of RMB and treatment. We evaluated the impact of RMB on management by analyzing the proportion of high-grade disease on final pathology as a surrogate for risk stratification. RESULTS: We identified 36,720 healthy-ACCI, 2,516 frail-ACCI, and 18,989 reference-ACCI patients. Healthy-ACCI patients were less likely to undergo RMB (7.5% versus 10.8%; p < 0.001) while frail-ACCI patients underwent RMB at similar rates (11.8% versus 10.8%; p = 0.14) compared with reference-ACCI patients. On multivariable logistic regression, in both healthy-ACCI and frail-ACCI patients, RMB was associated with decreased odds of surgical treatment, and increased odds of ablation and surveillance (all p < 0.01). In the frail-ACCI patients, higher grade disease at surgery was identified in the RMB cohort (32.9% versus 23.5%, p = 0.05). CONCLUSIONS: RMB is performed less frequently in healthy-ACCI patients compared with the reference cohort. RMB is associated with decreased odds of surgical treatment and increased odds of surveillance and ablation in all cohorts. In frail-ACCI patients who underwent surgery, RMB may provide additional risk stratification as these patients had lower rates of low-grade disease.

Financial Margins for Prostate Cancer Surgery: Quantifying the Impact of Modifiable Cost Inputs in an Episode Based Reimbursement Model.

PURPOSE: The United States health care system is rapidly moving away from fee for service reimbursement in an effort to improve quality and contain costs. Episode based reimbursement is an increasingly relevant value based payment model of surgical care. We sought to quantify the impact of modifiable cost inputs on institutional financial margins in an episode based payment model for prostate cancer surgery. MATERIALS AND METHODS: A total of 157 consecutive patients underwent robotic radical prostatectomy in 2016 at a tertiary academic medical center. We compiled comprehensive episode costs and reimbursements from the most recent urology consultation for prostate cancer through 90 days postoperatively and benchmarked the episode price as a fixed reimbursement to the median reimbursement of the cohort. We identified 2 sources of modifiable costs with undefined empirical value, including preoperative prostate magnetic resonance imaging and perioperative functional recovery counseling visits, and then calculated the impact on financial margins (reimbursement minus cost) under an episode based payment. RESULTS: Although they comprised a small proportion of the total episode costs, varying the use of preoperative magnetic resonance imaging (33% vs 100% of cases) and functional recovery counseling visits (1 visit in 66% and 2 in 100%) reduced average expected episode financial margins up to 22.6% relative to the margin maximizing scenario in which no patient received these services. CONCLUSIONS: Modifiable cost inputs have a substantial impact on potential operating margins for prostate cancer surgery under an episode based payment model. High cost health systems must develop the capability to analyze individual cost inputs and quantify the contribution to quality to inform value improvement efforts for multiple service lines.

Testosterone Therapy on Active Surveillance and Following Definitive Treatment for Prostate Cancer.

PURPOSE OF REVIEW: Previously considered an absolute contraindication, the use of testosterone therapy in men with prostate cancer has undergone an important paradigm shift. Recent data has changed the way we approach the treatment of testosterone deficiency in men with prostate cancer. In the current review, we summarize and analyze the literature surrounding effects of testosterone therapy on patients being treated in an active surveillance protocol as well as following definitive treatment for prostate cancer. RECENT FINDINGS: The conventional notion that defined the relationship between increasing testosterone and prostate cancer growth was based on limited studies and anecdotal case reports. Contemporary evidence suggests testosterone therapy in men with testosterone deficiency does not increase prostate cancer risk or the chances of more aggressive disease at prostate cancer diagnosis. Although the studies are limited, men who received testosterone therapy for localized disease did not have higher rates of recurrences or worse clinical outcomes. Current review of the literature has not identified adverse progression events for patients receiving testosterone therapy while on active surveillance/watchful waiting or definitive therapies. The importance of negative effects of testosterone deficiency on health and health-related quality of life measures has pushed urologists to re-evaluate the role testosterone plays in prostate cancer. This led to a paradigm shift that testosterone therapy might in fact be a viable option for a select group of men with testosterone deficiency and a concurrent diagnosis of prostate cancer.

Risk factors for recurrence after surgery in non-metastatic RCC with thrombus: a contemporary multicentre analysis.

OBJECTIVE: To determine the predictors of post-surgical recurrence for patients with non-metastatic renal cell carcinoma (RCC) and venous thrombus. METHODS: Records from consecutive patients with non-metastatic RCC with tumour thrombus, treated surgically between 2000 and 2012 at one of three centres, were reviewed. Univariable and multivariable analysis were used to evaluate the association of risk factors for post-surgical recurrence. RESULTS: A total of 465 patients with non-metastatic RCC were identified, including patients with thrombus present in the renal vein (257 patients, 55.3%), infrahepatic inferior vena cava (IVC; 144 patients, 31.0%) and suprahepatic IVC (64 patients, 13.8%). The median (interquartile range) follow-up was 28.3 (12.2-56.4) months, with metastatic RCC developing in 188 patients (40.5%). Independent predictors of recurrence included: body mass index ≤20 kg/m(2) (hazard ratio [HR] 2.66; 95% confidence interval [CI] 1.29-5.49), low preoperative haemoglobin (HR 1.54; 95% CI 1.07-2.20), perinephric fat invasion (HR 1.51; 95% CI 1.09-2.10), IVC thrombus height (HR 2.64; 95% CI 1.47-4.74), tumour diameter (HR 1.04 95% CI 1.00-1.09), nuclear grade (HR 1.56 95% CI 1.12-2.15) and non-clear-cell histology (HR 2.13; 95% CI 1.30-3.50). Independently predictive variables were used to create a recurrence model for three risk groups based on 0, 1-2, or >2 risk factors, respectively. The 5-year recurrence-free survival rate was significantly different in patients with favourable-risk (79.1%) compared with intermediate- (55.1%) or high-risk (22.1%) disease (P < 0.001). CONCLUSIONS: Seven risk factors for recurrence were identified for patients with non-metastatic RCC with thrombus, which can be used to select patients who may benefit from increased surveillance or adjuvant therapy clinical trials.

Preoperative predictors of pathological lymph node metastasis in patients with renal cell carcinoma undergoing retroperitoneal lymph node dissection.

PURPOSE: Patients with locally advanced renal cell carcinoma represent a subset that may benefit from retroperitoneal lymph node dissection. We identified preoperative clinical predictors of positive lymph nodes in patients with renal cell carcinoma without distant metastasis who underwent retroperitoneal lymph node dissection. MATERIALS AND METHODS: We retrospectively analyzed data on a consecutive cohort of 1,270 patients with cTany Nany M0 renal cell carcinoma who were treated at a single institution from 1993 to 2012. Multivariate analysis was performed to determine preoperative predictors of pathologically positive lymph nodes in patients who underwent retroperitoneal lymph node dissection. A nomogram was developed to predict the probability of lymph node metastasis. Overall, cancer specific and recurrence-free survival was estimated using the Kaplan-Meier Method. RESULTS: We identified 1,270 patients with renal cell carcinoma without distant metastasis who had (564) or did not have (706) retroperitoneal lymph node dissection performed. Of the 564 patients 131 (23%) and 433 (77%) had pN1 and pN0 disease, and 60 (37%) and 29 (7.2%) had cN1pN0 and cN0pN1 disease, respectively. ECOG PS, cN stage, local symptoms and lactate dehydrogenase were associated with nodal metastasis on multivariable analysis. A nomogram was developed with a C-index of 0.89 that demonstrated excellent calibration. Differences in overall, cancer specific and recurrence-free survival among pNx, pN0 and pN1 cases were statistically significant (p <0.001). CONCLUSIONS: Local symptoms, ECOG PS, cN stage and lactate dehydrogenase were independent predictors of lymph node metastasis in patients who underwent retroperitoneal lymph node dissection. Our predictive nomogram using these factors showed excellent discrimination and calibration.

Merit-based Incentive Payment System Quality Reporting in Urology Practices.

INTRODUCTION: Most urologists are required to participate in Merit-based Incentive Payment System-an alternative payment model in which physicians must track and report quality measures. However, Merit-based Incentive Payment System measures are urology-specific, and it remains unclear what measures urologists are choosing to track and report. METHODS: We performed a cross-sectional analysis of Merit-based Incentive Payment System measures reported by urologists for the most recent performance year. Urologists were categorized by their reporting affiliation (ie, individual, group, or alternative payment model). We identified the measures most frequently reported by urologists. Among reported measures, we identified those that were specific to urological conditions and those that were "topped out" (ie, measures considered indiscriminate by Medicare because high performance is easily achieved). RESULTS: A total of 6,937 urologists reported in Merit-based Incentive Payment System during the 2020 performance year, of whom 14% reported as an individual, 56% as a group, and 30% as an alternative payment model. Among the top 10 most frequently reported measures, none were urology-specific. Eleven percent of urologists reported measures that were directly specific to urological conditions; 65% of individual urologists, 58% of those in groups, and 92% in alternative payment models reported at least 1 or more "topped out" measures. CONCLUSIONS: Most measures reported by urologists are not specific to urological conditions, and therefore performance within Merit-based Incentive Payment System may be a poor indicator of the quality of urological care provided. As Medicare transitions Merit-based Incentive Payment System to implement specific quality measures, the urological community will need to develop and submit measures that will be most impactful for urology patients.

Rural For-Profit Hospitals Are Associated With Higher Commercial Prices for 3 Common Urological Procedures.

INTRODUCTION: Rural patients lack access to urological services, and high local prices may dissuade underinsured patients from surgery. We sought to describe commercially insured prices for 3 urological procedures at rural vs metropolitan and for-profit vs nonprofit hospitals. METHODS: A cross-sectional analysis of commercially insured prices from the Turquoise Health Transparency data set was performed for ureteroscopy with laser lithotripsy, transurethral resection of bladder tumor, and transurethral resection of prostate. Hospital characteristics were linked using the Centers for Medicare and Medicaid Services Healthcare Cost Reporting Information System. Linear modeling analyzed median hospital price and its association with hospital characteristics. RESULTS: Overall, 1,532 hospitals reported urological prices in Turquoise. Median prices for each procedure were higher at rural for-profits (ureteroscopy $16,522, transurethral resection of bladder tumor $5,393, transurethral resection of prostate $9,999) vs rural nonprofits (ureteroscopy $4,512, transurethral resection of bladder tumor $2,788, transurethral resection of prostate $3,881) and metropolitan for-profits (ureteroscopy $5,411, transurethral resection of bladder tumor $3,420, transurethral resection of prostate $4,874). Rural for-profit status was independently associated with 160% higher price for ureteroscopy (relative cost ratio 2.60, P < .001), 50% higher for transurethral resection of bladder tumor (relative cost ratio 1.50, P = .002), and 113% higher for transurethral resection of prostate (relative cost ratio 2.13, P < .001). CONCLUSIONS: Prices are higher for 3 common urological surgeries at rural for-profit hospitals. Differential pricing may contribute to disparities for underinsured rural residents who lack access to nonprofit facilities. Interventions that facilitate transportation and price shopping may improve access to affordable urological care.

Financial Health of People Living With Dementia and Their Informal Care Partners: Protocol for a Mixed Methods Study.

BACKGROUND: There is a growing body of academic literature focusing on the significant financial burdens placed on people living with cancer, but little evidence exists on the impact of rising costs of care in other vulnerable populations. This financial strain, also known as financial toxicity, can impact behavioral, psychosocial, and material domains of life for people diagnosed with chronic conditions and their care partners. New evidence suggests that populations experiencing health disparities, including those with dementia, face limited access to health care, employment discrimination, income inequality, higher burdens of disease, and exacerbating financial toxicity. OBJECTIVE: The three study aims are to (1) adapt a survey to capture financial toxicity in people living with dementia and their care partners; (2) characterize the degree and magnitude of different components of financial toxicity in this population; and (3) empower the voice of this population through imagery and critical reflection on their perceptions and experiences relating to financial toxicity. METHODS: This study uses a mixed methods approach to comprehensively characterize financial toxicity among people living with dementia and their care partners. To address aim 1, we will adapt elements from previously validated and reliable instruments, including the Comprehensive Score for Financial Toxicity and Patient-Reported Outcomes Measurement Information System, to develop a financial toxicity survey specific to dyads of people living with dementia and their care partners. A total of 100 dyads will complete the survey, and data will be analyzed using descriptive statistics and regression models to address aim 2. Aim 3 will be addressed using the process of "photovoice," which is a qualitative, participatory research method that combines photography, verbal narratives, and critical reflection by groups of individuals to capture aspects of their environment and experiences with a certain topic. Quantitative results and qualitative findings will be integrated using a validated, joint display table mixed methods approach called the pillar integration process. RESULTS: This study is ongoing, with quantitative findings and qualitative results anticipated by December 2023. Integrated findings will enhance the understanding of financial toxicity in individuals living with dementia and their care partners by providing a comprehensive baseline assessment. CONCLUSIONS: As one of the first studies on financial toxicity related to dementia care, findings from our mixed methods approach will support the development of new strategies for improving the costs of care. While this work focuses on those living with dementia, this protocol could be replicated for people living with other diseases and serve as a blueprint for future research efforts in this space. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47255.

Association of Rural Hospital for-Profit Status With Higher Publicly Reported Prices for the Components of Inpatient Hematuria Evaluation Among Commercially Insured Patients.

INTRODUCTION: Rural patients have limited access to urological care and are vulnerable to high local prices. Little is known about price variation for urological conditions. We aimed to compare reported commercial prices for the components of inpatient hematuria evaluation between for-profit vs not-for-profit and rural vs metropolitan hospitals. METHODS: We abstracted commercial prices for the components of intermediate- and high-risk hematuria evaluation from a price transparency data set. We compared hospital characteristics between those that do and do not report prices for a hematuria evaluation using the Centers for Medicare and Medicaid Services Healthcare Cost Reporting Information System. Generalized linear modelling evaluated the association between hospital ownership and rural/metropolitan status with prices of intermediate- and high-risk evaluations. RESULTS: Of all hospitals, 17% of for-profits and 22% of not-for-profits report prices for hematuria evaluation. For intermediate-risk, median price at rural for-profit hospitals was $6,393 (interquartile range [IQR] $2,357-$9,295) compared to $1,482 (IQR $906-$2,348) at rural not-for-profits and $2,645 (IQR $1,491-$4,863) at metropolitan for-profits. For high-risk, rural for-profit hospitals' median price was $11,151 (IQR $5,826-$14,366) vs $3,431 (IQR $2,474-$5,156) at rural not-for-profits and $4,188 (IQR $1,973-$8,663) at metropolitan for-profits. Rural for-profit status was associated with an additional higher price for intermediate- (relative cost ratio 1.62, 95% CI 1.16-2.28, P = .005) and high-risk evaluations (relative cost ratio 1.50, 95% CI 1.15-1.97, P = .003). CONCLUSIONS: Rural for-profit hospitals report high prices for components of inpatient hematuria evaluation. Patients should be aware of prices at these facilities. These differences may dissuade patients from undergoing evaluation and lead to disparities.

The Impact of Health Delivery Integration on Cancer Outcomes.

Although integrated health care has largely been associated with increases in prices and static or decreased quality across many disease states, it has shown some successes in improving cancer care. However, its impact is largely equivocal, making consensus statements difficult. Critically, integration does not necessarily translate to clinical coordination, which might be the true driver behind the success of integrated health care delivery. Moving forward, it is important to establish payment models that support clinical care coordination. Shifting from a fragmented health system to a coordinated one may improve evidence-based cancer care, outcomes, and value for patients.

Access to Urological Care for Medicaid-Insured Patients at Urology Practices Acquired by Private Equity Firms.

OBJECTIVE: To characterize appointment access for Medicaid-insured patients seeking care at urology practices affiliated with private equity firms in light of the recent national trends in practice consolidation. METHODS: We identified 214 urology offices affiliated with private equity firms that were geographically matched with 231 non-private equity affiliated urology offices. Using a standardized script, researchers posed as an adult patient with either Medicaid or commercial insurance in the clinical setting of new onset, painless hematuria. The primary outcome was whether the patient's insurance was accepted for an appointment. The secondary outcome was appointment wait time. RESULTS: We conducted 815 appointment inquiry calls to 214 private equity (PE) and 231 non-PE-affiliated urology offices across 12 states. Appointment availability was higher for commercially-insured patients (99.0%; 95% CI: 98.1%-99.9%) vs Medicaid-insured patients (59.8%; 95% confidence interval [CI]: 55.0%-64.6%) (P < .0001). Medicaid acceptance was higher at non-PE affiliated (66.8%; CI 60.4%-73.2%) than PE-affiliated practices (52.1%; 95% CI 45.0%-59.2%) (P = .003). On multivariable logistic regression analysis, state Medicaid expansion status (odds ratio [OR] 2.20; CI 1.14-4.28; P = .020) was independently associated with Medicaid appointment availability, whereas PE-affiliation (OR 0.55; CI 0.37-0.83; P = .004) was independently associated with lower Medicaid access. Appointment wait times did not differ significantly for commercially-insured vs Medicaid patients (19.2 vs 20.1 days; p = .59), but PE-affiliated practices offered shorter mean wait times than non-PE offices (17.5 vs 21.4 days; P = .017). CONCLUSION: Access disparities for urologic evaluation in patients with Medicaid insurance at urology practices and were more pronounced at private equity acquired practices.

Long term cost comparisons of radical cystectomy versus trimodal therapy for muscle-invasive bladder cancer.

BACKGROUND: Earlier studies on the cost of muscle-invasive bladder cancer treatments are limited to short-term costs of care. We determined the 2- and 5-year costs associated with trimodal therapy (TMT) vs. radical cystectomy (RC). METHODS: We performed a retrospective cohort study using the Surveillance, Epidemiology, and End Results (SEER)-Medicare database. Total Medicare costs at 2 and 5 years following RC vs. TMT were compared using inverse probability of treatment-weighted propensity score models. RESULTS: A total of 2,537 patients aged 66 to 85 years were diagnosed with clinical stage T2-4a muscle-invasive bladder cancer. Total median costs for patients that received no definitive treatment(s) were $73,780 and $88,275 at 2-and 5-years. Costs were significantly higher for TMT than RC at 2-years ($372,839 vs. $191,363, Median Difference $127,815, Hodges-Lehmann Estimate (H-L) 95% Confidence Interval (CI), $112,663-$142,966) and 5-years ($424,570 vs. $253,651, Median Difference $124,466, H-L 95% CI, $105,711-$143,221). TMT had higher outpatient costs than RC (2-years: $318,221 vs. $100,900; 5-years: $367,092 vs. $146,561) with significantly higher costs with radiology, medications, pathology/laboratory, and other professional services. RC had higher inpatient costs than TMT (2-years: $62,240 vs. $33,631, Median Difference $-29,174, H-L 95% CI, $-32,364-$-25,984; 5-years: $75,499 vs. $45,223, Median Difference $-29,843, H-L 95% CI, $-33,905-$-25,781). CONCLUSIONS AND RELEVANCE: The excess spending associated with trimodal therapy vs. radical cystectomy was largely driven by outpatient expenditures. The relatively high long-term trimodal therapy costs are prime targets for cost containment strategies to optimize future value-based care.

Peripherally Acting µ-Opioid Receptor Antagonists in the Management of Postoperative Ileus: a Clinical Review.

Postoperative ileus (POI) and constipation are common secondary effects of opioids and carry significant clinical and economic impacts. µ-Opioid receptors mediate opioid analgesia in the central nervous system (CNS) and gastrointestinal-related effects in the periphery. Peripherally acting µ-opioid receptor antagonists (PAMORAs) block the peripheral effects of opioids in the gastrointestinal tract, while maintaining opioid analgesia in the CNS. While most are not approved for POI or postoperative opioid-induced constipation (OIC), PAMORAs have a potential role in these settings via their selective effects on the µ-opioid receptor. This review will discuss recent clinical trials evaluating the safety and efficacy of PAMORAs, with a focus on alvimopan (Entereg®) and methylnaltrexone (Relistor®) in patients with POI or postoperative OIC. We will characterize potential factors that may have impacted the efficacy observed in phase 3 trials and discuss future directions for the management and treatment of POI.

The role of neoadjuvant chemotherapy, lymph node dissection, and treatment delay in patients with muscle-invasive bladder cancer undergoing partial cystectomy.

OBJECTIVES: To investigate treatment patterns of partial cystectomy (PC), neoadjuvant chemotherapy (NAC), lymph node dissection (LND), and treatment delays, and the associations with overall survival (OS) among patients with muscle-invasive bladder cancer. PATIENTS AND METHODS: We identified patients with cT2-4cN0cM0 urothelial carcinoma of the bladder in the National Cancer Database who underwent PC from 2007 through 2015. We performed descriptive statistics and assessed temporal trends using the Cochrane-Armitage test. Our outcomes of interest were NAC, LND, and treatment delay defined as ≥8 or ≥12 weeks for patients who underwent NAC or upfront surgery, respectively. We used logistic regression and multivariable Cox proportional hazards models to evaluate predictors and associations with OS, respectively. RESULTS: A total of 9,199 patients met inclusion criteria. Over the study period, PC utilization decreased from 9% to 7% (P = 0.06). Compared with patients who underwent radical cystectomy, patients treated with PC less frequently received NAC (7% vs. 17%, P < 0.01) and LND (57% vs. 91%, P < 0.01), but were less likely to experience treatment delays (25% vs. 31%, P < 0.01). Only 4.1% (27/655) of patients treated with PC received the combination of NAC, LND, and no treatment delay. In a Cox model, adequacy of LND was associated with improved OS (<10 nodes: HR 0.62, 95% CI 0.48-0.81 and ≥10 nodes: HR 0.48, 95% Cl 0.32-0.72). CONCLUSION: PC is uncommon and associated with poorer utilization of NAC and LND, but fewer treatment delays. The adequacy of LND was associated with improved OS while NAC and treatment delay were not.

Trends in management of ureteral urothelial carcinoma and effects on survival: a hospital-based registry study.

BACKGROUND: High-risk ureteral tumors represent an understudied subset of upper tract urothelial carcinoma, whose surgical management can range from a radical nephroureterectomy (NU) to segmental ureterectomy (SU). OBJECTIVES: To evaluate contemporary trends in the management of high-risk ureteral tumors, the utilization of lymphadenectomy and peri-operative chemotherapy, and their impact on overall survival (OS). DESIGN, SETTING, AND PARTICIPANTS: We performed a retrospective cohort study of patients in the National Cancer Database from years 2006 to 2013 with clinically localized high-risk ureteral tumors treated with NU or SU. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Chi-squared tests were utilized to assess differences in clinicodemographic features and peri-operative treatment delivery between SU and NU cohorts. Cochran-Armitage tests and linear regressions were performed to evaluate temporal trends in treatment utilization. Multivariable logistic regression models were employed to assess predictors of treatment delivery. Multivariable Cox proportional hazards models evaluated associations with OS. RESULTS: Of the 1,962 patients included, NU was more commonly performed than SU (72.4%, 1,421/1,962 vs. 27.6%, 541/1,962). Only 22.7% (446/1,962) of the population underwent lymphadenectomy, and 24.8% (271/1,092) of those with advanced pathology (≥pT2 or pN+) received adjuvant chemotherapy. Lymphadenectomy was associated with improved OS in NU patients when more than 3 nodes were removed (hazard ratio [HR] 0.58, 95% confidence interval [CI] 0.39-0.89). Receipt of adjuvant chemotherapy for advanced pathology had no impact OS in both the NU (HR 1.10, 95% CI 0.84-1.44) and SU (HR 0.94, 95% CI 0.61-1.46) cohorts. Performance of SU was not associated with poorer OS on multivariable analysis (HR 1.02, 95% CI 0.89-1.21, P = 0.83). CONCLUSION: Our study suggests that SU may be an appropriate alternative to NU for the management of high-risk ureteral tumors. Further, lymphadenectomy may play an important role at the time of NU, and adjuvant chemotherapy is infrequently utilized in patients with advanced pathology.

Predictors of adequate lymph node dissection in patients with non-muscle invasive bladder cancer undergoing radical cystectomy and effect on survival.

INTRODUCTION: Radical cystectomy (RC) is the standard of care for refractory high-risk non-muscle invasive bladder cancer (NMIBC). We aim to identify predictors of adequate lymph node dissection (LND) in a cohort of NMIBC patients undergoing RC, as well as its impact on clinical outcomes. METHODS: The National Cancer Database was queried for patients who underwent RC for urothelial cell carcinoma for clinical stage Tis/a/1 N0M0 disease between 2004 and 2013. Patients were stratified by LND: none, inadequate (<10) or adequate (≥10 nodes). Factors associated with LND were analyzed. Inverse-probability weighted propensity score matching was used to assess the impact of adequate LND on overall survival. RESULTS: The final cohort of 3,226 patients had a median follow-up of 39.0 months, had a mean age of 65.3 years, was 70% male, and was 81% Caucasian. Overall, 16.6% received no LND, 28.5% inadequate LND, and 55.0% adequate LND. Treatment at an academic facility, Charlson-Deyo Comorbidity score of 1, and later year of treatment were significantly associated with adequate LND. Overall survival was significantly higher with adequate LND compared to a matched-cohort of inadequate LND patients (68.7% vs. 60.6% at 5 years, P < 0.01). CONCLUSIONS: Nearly half of NMIBC patients undergoing RC do not receive an adequate LND, despite an association with increased overall survival. Treatment at an academic facility was associated with increased likelihood of adequate LND. Initiatives to improve adequate LND in this population may be warranted.

Impact of Diagnosing Urologists and Hospitals on the Use of Radical Cystectomy.

BACKGROUND: One out of five patients with muscle-invasive bladder cancer undergo radical cystectomy-a guideline-recommended treatment. Previous studies have primarily evaluated patient characteristics associated with the use of radical cystectomy, ignoring potential nesting of data. OBJECTIVE: To determine the impact of patient, diagnosing urologist, and hospital characteristics on the variation in the use of radical cystectomy. DESIGN SETTING AND PARTICIPANTS: This is a retrospective cohort study using the Surveillance, Epidemiology, and End Results Registry (SEER)-Medicare linked database. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: A total of 7097 muscle-invasive bladder cancer patients and 4601 diagnosing urologists affiliated to 822 hospitals from January 1, 2002 to December 31, 2012 were analyzed. Multilevel logistic regression analyses were used to determine variation and factors associated with the use of radical cystectomy. RESULTS AND LIMITATIONS: Of the 7097 patients, only 27% underwent radical cystectomy. The intraclass correlation coefficient for variation in the use of radical cystectomy attributed to the hospital level was 4.3%. Higher radical cystectomy volume by diagnosing urologists (more than five vs zero to one surgery: odds ratio [OR], 1.27; 95% confidence interval [CI], 1.00-1.62) and hospitals (more than five vs zero to four surgeries: OR,1.48; 95% CI, 1.14-1.93) was associated with increased use of radical cystectomy. Patients diagnosed by female rather than male urologists were more likely to undergo radical cystectomy (OR, 1.32; 95% CI, 1.07-1.62). CONCLUSIONS: We found that 4.3% variation in the use of radical cystectomy was attributed to the hospital level, leaving 95.7% variation in use unexplained. We identified significantly increased use among higher-volume and female diagnosing urologists. These findings support further investigation into measures beyond hospital volume, which largely impact the utilization of radical cystectomy. PATIENT SUMMARY: In this large population-based study, we found that 4.3% of variation in the use of radical cystectomy was attributed to the hospital level, leaving 95.7% variation in use unexplained. Higher radical cystectomy volume of diagnosing urologists and female urologists were independently associated with increased use of radical cystectomy. These findings support further investigation into measures beyond hospital volume, which largely impact the utilization of radical cystectomy.